BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3122853 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-08004
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 23, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER; PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TELEMETRY WAS INTERRUPTED WHILE UPDATING THE PUMP. THE PUMP WAS INTERROGATED AND WAS FOUND TO BE IN A STOPPED PUMP MODE FOR THE PAST ONE MINUTE. THE PUMP WAS UPDATED AND THE ISSUE WAS RESOLVED. THE PUMP WAS DELIVERING BACLOFEN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE ISSUE WAS RESOLVED THE DAY OF THE REFILL. THE PATIENT WAS SENT HOME AND WAS DOING FINE AT THE END OF THE REFILL. THE CAUSE OF THE TELEMETRY ISSUE WAS UNKNOWN, BUT IT HAD NOT HAPPENED AGAIN DURING ANY PATIENT REFILLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224543 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1